FIG. 1 illustrates a typical scenario that patients and physicians are faced with in the case of chronic sinus disease. A diseased maxillary sinus cavity 10 of patient P has become circumferentially swollen with thickening of the lining mucosa 11. In a healthy maxillary sinus cavity 12, mucosa 13 thinly lines the cavity. Maxillary sinus cavity 12 is located below orbit 14, and frontal sinus 16 is located above orbit 14. The sphenoid sinus is located in the high posterior nasal cavity. Sinus disease is often a result of allergic or inflammatory swelling in the nasal airway 18, which frequently causes swelling in other nasal structures such as turbinates 20. This not only causes obstruction of nasal airway 18, but also the small openings, or ostia, which would normally allow for ventilation and drainage from sinus cavities 22.
Conventional methods for treating chronic sinus disease have largely been directed to surgery by an otolaryngology (ENT) physician to correct the obstructive problems in the nose and paranasal sinuses. Treatment of sinus problems has assumed a top-five position in the ranking of expense in adult care in the United States in recent years. In many, if not most, instances, surgery has developed a reputation of futility since the number patients undergoing repeat surgical procedures is unacceptably high.
Recent advances toward minimizing sinus disease recurrence and optimizing surgical results have followed from the understanding that preservation of normal, healthy mucosa in the periphery of the surgical target site is paramount. This is particularly true in the area of the sinus ostia, where exposed bone or traumatized mucosa after sinus surgery has a robust ability to form circumferential and obstructive scar tissue which often completely closes off the sinus opening in as little as a few weeks. Combined experience with this problem has demonstrated that this obstructive process tends to occur within the first six weeks following surgery.
This timeframe for restenosis closely follows that of the now quite well understood inflammation process and the timetable of early fibrosis formation in other regions in human tissue. Taking preservation of mucosa to the ultimate degree has recently led to the usage of balloon dilational devices in the nose for expanding the sinus ostia while leaving the lining mucosa intact. However, the use of sinoplasty with a balloon catheter is of relatively limited value since it does not maintain patent paranasal ostia when obstructive or inflammatory phenomena occur after surgery.